US-Conference on Fixed-Dose Combination (FDC) Drug Products in
Botswana March 29-30, 2004:
The US challenge to the WHO drug pre qualification scheme, risk
depriving poor patients from basic treatment

Oxfam, March 26, 2004

Treatment programmes which save the lives of HIV/AIDS patients are under
threat from the hostility of the major pharmaceutical companies towards
generic drug production in developing countries. The WHO 3X5 strategy
plans to treat 3 million HIV people by the year 2005 and the Global Fund
is already financing treatment programmes in many countries. The US
HIV/AIDS emergency plan also aims to scale up treatment in 24 countries.

Such programmes depend on using quality medicines at the lowest price
and on using fixed dose combinations of AIDS medicines (FDCs), which
enhance patients=92 compliance and decrease the chances of developing
resistance. The price of relevant brand name drugs ($562) is more than
three times the price of the WHO=92s recommended generic FDC ($ 140). But
the US government, under the influence of major pharmaceutical companies
is now attempting to undermine the validity of the WHO pre-qualification
scheme, which vets and approves the quality of medicines including cheap
generic versions of patented medicines legally produced in countries
such as India and China. If successful, the US challenge would prevent
treatment programmes from using the cheaper generic medicines and thus
deprive poor patients of simple FDCs treatment.

The forthcoming US-sponsored conference in Botswana on FDCs risks
confusing developing countries who are already implementing treatment
programmes using FDCs, and may dissuade them from using such medicines
approved by the WHO pre-qualification scheme. This could have drastic
consequences for prescribers and patients, requiring them to change to
different drug regimes.

Many of the Indian companies vetted by the WHO are already approved by
the US Food and Drug Administration (FDA) to sell medicines for the US
market. Cipla, the producer of the basic FDC, has been approved by the
FDA since 1985. The company sells it Active Pharmaceutical Ingredients
to US-based producers. American patients are already using Flutamide, a
Cipla product for the treatment of cancer.

WHO is mandated to support developing countries to ensure access to
essential medicines. The Pre-qualification Scheme has been set up to
ensure that procurement is based on assured quality, including of
generic drugs and FDCs and is successfully doing that. There are three
reasons why WHO should be supported to continue pre-qualification.

Second, it validates the purchase of FDCs of drugs that simplify
treatment, and therefore decrease chances of resistance.

Third, through providing a shortcut for developing country procurement
units, it supports weak pharmaceutical systems to manage the supply
cycle better.

The major pharmaceutical companies and the US government must now
recognise the crucial role of generic medicines in public health. Oxfam
urges the US government to stop concentrating on enhancing profits of US
companies and focus instead on the real issue of treating patients. If
the US money is used to purchase only FDA approved drugs, it would make
it much more difficult for countries to manage multiple treatment
schemes and to monitor resistance. All donors, including the US, should
strengthen WHO to undertake its core normative functions, including
pre-qualification. At the end of the day pharma and generics should work
together to provide life saving medicines for HIV patients in developing
countries.